Exact FDA event identifier

Event 94780

5 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: June 03, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Microtek Medical Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Z-2639-2024

Recall number: Z-2639-2024
Initiated: June 03, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Microtek Medical Inc.
Quantity: 10,366 cases (518,300 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

Code information

SKU/UDI-Device Identifier: 2000S/00748426002085; Lot Numbers: 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Distribution pattern

Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

device · product 2 of 5

Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Z-2640-2024

Recall number: Z-2640-2024
Initiated: June 03, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Microtek Medical Inc.
Quantity: 135,999 cases (6,799,950 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

Code information

SKU/UDI-Device Identifier: 2002S/00748426002399; Lot Numbers: 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Distribution pattern

Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

device · product 3 of 5

Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Z-2641-2024

Recall number: Z-2641-2024
Initiated: June 03, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Microtek Medical Inc.
Quantity: 163 cases (8,150 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

Code information

SKU/UDI-Device Identifier: 2004S/00748426002498; Lot Numbers: 200328,220321,220321,221220,221220,221102,220321,181127,220321,210506,200328,181127,200328,181127,181127,181127,200328,200328,180625,191113,220321,220321,220321,220321,210506,210506,210109,191113,200328,201115,200328,181127,181127,200328,181127,181127,181127,210506,191113,191113,180625,181127,221220,221102,220321,181127,220321,210506,210506,191113,200328,220321,220321,220321,200328,220321,220321,210506,210506,221220,221102,220321,180625,210109,191113,181127,210506,210506,181127,200328,200328,180625,180625,180625,181127,181127,180625,200328,191113,191113,181127,191113,200328,200328,220321,220321,220321,210506,210506,210506,210506,210109,200328,200328,200328,200328,200328,200328,200328,191113,181127,181127,200328,181127,181127,181127,181127,181127,200328,191113,191113,181127,180625,181127,221220,200328,181127,181127,200328,220321,220321,200328,210506,210506,210506,210506,210109,210109,201115,191113,200328,200328,200328,200328,200328,181127,181127,181127,180625,180625,181127,200328,191113,180625,181127,180625,181127,181127,181127,221220,221220,221220,221220,221220,221220,221102,221102,221102,221102,221102,221102,221102,220321,220321,220321,220321,220321,220321,220321,220321,200328,200328,181127,181127,200328,181127,200328,191113,200328,191113,191113,220321,220321,220321,220321,220321,210506,210506,210506,210506,210506,210506,210506,210506,210506,210506,210109,210109,191113,200328,200328,200328,200328,200328,200328,181127,181127,200328,181127,200328,191113,181127,180625,200328,181127,191113,200328,181127,181127,181127,220321,210506,210109,200328,200328,191113,200328,181127,221220,221102,220321,200328,181127,180625,180625,191113,200328,200328,221102,220321,220321,191113,181127,181127,181127,210109,210109,200328,200328,200328,181127,221102,221220,221220,221220,221102,221102,221102,220321,220321,220321,181127,200328,200328,181127,181127,200328,181127,220321,210506,210506,210109,200328,200328,200328,200328,200328,200328,181127,181127,191113,181127,191113,200328,180625,180625,200328,181127,180625,181127,200328,220321,181127,221220,221220,221220,221220,221220,221220,221220,221220,221220,221102,221102,221102,221102,220321,220321,220321,220321,220321,220321,181127,210109,191113,191113,181127,220321,181127,191113,220321,200328,181127,221220,221220,220321,191113,191113,220321,191113,191113,200328,210109,210109,201115,201115,210109,200328,200328,191113,181127,181127,210506,221220,221220,221220,221220,221220,221220,221220,221220,221102,221102,220321,220321,220321,200328,221220,221102,180625,181127,181127,180625,191113,210506,210109,191113,200328,181127,200328,181127,180625,200328,221220,221220,221220,221102,221102,221102,220321,220321,220321

Distribution pattern

Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

device · product 4 of 5

Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Z-2642-2024

Recall number: Z-2642-2024
Initiated: June 03, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Microtek Medical Inc.
Quantity: 30,435 cases (1,521,750 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

Code information

SKU/UDI-Device Identifier: 2006S/00748426002511; Lot Numbers: 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Distribution pattern

Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

device · product 5 of 5

Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Z-2643-2024

Recall number: Z-2643-2024
Initiated: June 03, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Microtek Medical Inc.
Quantity: 11,781 cases (589,050 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

Code information

SKU/UDI-Device Identifier: 2008S/00748426002535; Lot Numbers: 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5,230325,230326,221117,221112,221112,211116,220525,220406,220406,220102,231027,230629,230626,230629,230608,230608,230629,230607,230509,230326,230325,221112,220526,211115,220525,220530,220103,210807,210805,201112,201112,200818,190527,190717,190717,190312,190507,181022,211117,210922,210922,210922,210922,210807,210706,210419,210415,210415,210416,210416,201111,201111,201110,201113,201112,201110,201020,200818,200702,181224,181224,190312,181224,180828,230628,230628,230608,230608,230607,230607,230629,230629,230509,230509,230324,230326,230325,221117,221112,211116,211115,220525,220417,220527,220407,220407,220407,220103,190828,181022,181224,181224,190717,190828,190312,190718,190828,190828,211117,210922,210923,210807,210923,210924,210805,210807,210805,210805,210805,210706,210804,210419,210419,210415,210415,201111,210104,210104,181225,181022,190410,190410,190410,190718,190828,181224,180828,181224,230608,230626,230629,230626,230629,230608,230608,230605,230605,230325,230326,230325,221117,221117,221112,221112,221112,221006,220525,221006,221011,221006,220528,220525,220528,220526,220528,221006,221006,211115,220525,220525,220526,220527,220530,220407,220102,230626,230629,220526,220102,210415,201112,200702,190528,190528,181022,210807,210706,210415,201111,201113,200818,200702,230626,230608,230607,230605,230325,221117,211115,220103,220103,220102,210706,210807,190507,230628,230627,230623,230629,230626,230605,230509,230326,230326,230326,230326,221117,221117,221112,221006,211116,211115,220815,220525,220417,220406,220530,220530,220527,220530,220407,211117,220103,220102,181022,181225,190312,190507,210922,210922,210807,210807,210805,210924,210706,210804,210419,210419,210415,210416,210416,210104,210104,201110,201110,201113,201113,201112,201112,201112,201020,201020,201019,201020,201019,201019,201020,200818,200818,200702,200702,190528,190527,181022,181226,181225,190410,181224,181226,180828,190312,190312,190312,190717,180828,190528,190528,190828,201110,201113,201112,201112,201112,201112,201112,201020,201020,201112,201019,200818,190313,190528,190528,181224,181022,181022,190312,190828,190527,190507,190528,181224,190312,190527,190828,210419,201111,201110,201020,200818,201020,180828,190410,190507,180828,181225,190410,230626,230623,230626,230605,230509,221117,221112,220525,220407,220407,220405,230629,230607,181224,190312,190312,190507,181226,181225,211117,211117,211117,210923,210807,210807,210706,210419,210419,210415,201111,201110,201113,201112,201020,200818,200702,190527,181226,181225,190718,190828,181224,181226,180828,230605,23

Distribution pattern

Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.